(54 days)
The Vision-Sciences EndoSheaths® are indicated for use as a protective covering for the scope during endoscopic examination of the upper airway, vocal chords and/or nasal passages.
The devices described in this 510(k) are sterile, disposable, sheaths designed to fit a variety of nasolaryngoscopes. The use of an EndoSheath® eliminates the need for high-level disinfection of the scope following each procedure.
The provided text describes a Special 510(k) Premarket Notification for a device modification, specifically for "Modified EndoSheath® for Flexible E". This document focuses on demonstrating substantial equivalence to predicate devices and adherence to design control requirements, rather than presenting a detailed study with acceptance criteria and device performance in the context of an AI/ML medical device.
Therefore, the requested information, which is highly pertinent to the validation of AI/ML medical devices (such as a table of acceptance criteria and reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment), is not present in the provided document.
The document primarily focuses on:
- Device Description: Sterile, disposable sheaths for nasolaryngoscopes.
- Indications for Use: Protective covering for the scope during endoscopic examination of the upper airway, vocal chords, and/or nasal passages.
- Safety and Performance: Mentions certification of compliance to 21 CFR 820.30 Design Control requirements and a Risk Analysis procedure. It lists "Validation testing including microbial barrier testing, tensile/elongation testing, leak testing, sheathed scope articulation testing and sheathed scope image quality evaluation" as being included in Design Validation and Verification planning. However, no specific results, acceptance criteria, or study details are provided.
- Conclusion: States that the modified EndoSheaths® are safe and effective based on indications for use, technological characteristics, and comparison to predicate devices.
In summary, this document does not contain the information required to answer the specific questions about acceptance criteria and a study proving the device meets those criteria, as typically expected for AI/ML device validation.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.